Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

JJJ 1980-04-10

HYDRAGAMMA 16

Applicant Innotron of Oregon, Inc.

K-Number K800601

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JOL 1980-04-10

C.C.-PAK

Applicant Respiratory Care, Inc.

K-Number K800635

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JDX 1980-04-10

PFIZER/AS&E 0450 LOCALIZER

Applicant Pfizer Medical Systems, Inc.

K-Number K800501

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IXL 1980-04-10

MULTI-FORMAT SFD MODEL 1720

Applicant Philips Medical Systems (Cleveland), Inc.

K-Number K800554

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IYO 1980-04-10

PORTABLE MEDICAL ULTRASOUND SCANNER

Applicant Bion Ent., Ltd.

K-Number K800434

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DRT 1980-04-10

D668 & D664 CENTRAL MONITORING SYSTEMS

Applicant Medtel Pty. , Ltd.

K-Number K800243

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BYI 1980-04-10

MJ PERCUSSOR

Applicant Cussionair Therapy Products, Inc.

K-Number K800713

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IYO 1980-04-10

S.K. DIAG. ULTRASOUND BODY SCANNER

Applicant Smithkline Diagnostics, Inc.

K-Number K800532

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CIT 1980-04-10

CENTRIFI CHEM AST/SGOT

Applicant Union Carbide Corp.

K-Number K800641

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FLS 1980-04-10

413A NEONATAL MONITOR

Applicant Xerox Corp.

K-Number K800164

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KLE 1980-04-10

ANT. & POST. RESTORATIVE POWDER LIQ.

Applicant American Dental Research

K-Number K800390

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DZB 1980-04-10

SNAP-WAY HEADGEAR

Applicant Northwest Orthodontics, Inc.

K-Number K800748

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